Tritanium X TL Instruments - intervertebral fusion device with bone graft, lumbar. Catalogs:TL Inserter (580220100), TL Draw Rod (580220101), Tube Set/Syringe Adapter Assembly (680220100), Syringe Plunger (680220102).
Check against the official notice below — it lists the full affected range.
Stryker Spine is recalling 169 Tritanium X TL intervertebral fusion device sets used in lumbar spine surgery. The recall affects sets distributed nationwide in Arizona, California, Colorado, Georgia, Kentucky, Massachusetts, Montana, North Carolina, Nebraska, New Jersey, New York, Ohio, Pennsylvania, and Wyoming. The devices contain non-conforming instruments including the TL Inserter, TL Draw Rod, Tube Set/Syringe Adapter Assembly, and Syringe Plunger components.
The non-conformances in these instruments could lead to device failure during a surgical procedure. The source document does not specify what remedy is available to affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
Stryker identified non-conforming instruments that are components of the Tritanium X TL sets. The firm found non-conformances with the TL Inserter, TL Draw Rod, Tube Set/Syringe Adapter Assembly, and Syringe Plunger that could lead to device failure during a procedure.
Reason for recall: Stryker identified non-conforming instruments that are components of the Tritanium X TL sets. The firm found non-conformances with the TL Inserter, TL Draw Rod, Tube Set/Syringe Adapter Assembly, and Syringe Plunger that could lead to device failure during a procedure. Distribution: US Nationwide distribution in the states of AZ, CA, CO, GA, KY, MA, MT, NC, NE, NJ, NY, OH, PA, WY. Quantity: 169 sets Lot/code info: (UDI): 07613327366310, 07613327366839680220102, 07613327366884, 07613327366457
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.